How To Prevent Dental Caries

Transcription

1 This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers patients and clinicians, health system leaders, and policymakers make more informed decisions and improve the quality of health care services.

2 Dental Caries Prevention: The Physician s Role in Child Oral Health Systematic Evidence Review Submitted to: Agency for Healthcare Research and Quality 540 Gaither Road Rockville, Maryland Submitted by: RTI International 3040 Cornwallis Road P.O. Box Research Triangle Park, North Carolina Contract No

3 Dental Caries Prevention: The Physician s Role in Child Oral Health Systematic Evidence Review Agency for Healthcare Research and Quality Contract # , Task Order No. 3 Technical Support for the U.S. Preventive Services Task Force James D. Bader, DDS, MPH* Gary Rozier, DDS, MPH Russell Harris, MD, MPH Kathleen N. Lohr, PhD * UNC School of Dentistry and Sheps Center for Health Services Research, Chapel Hill, NC. UNC School of Public Health, Chapel Hill, NC UNC Sheps Center for Health Services Research, Chapel Hill, NC RTI International, Research Triangle Park, NC and UNC School of Public Health, Chapel Hill, NC

4 Preface The Agency for Healthcare Research and Quality (AHRQ) sponsors the development of Systematic Evidence Reviews (SERs) through its Evidence-based Practice Program. With guidance from the U.S. Preventive Services Task Force (USPSTF) and input from Federal partners and primary care specialty societies, the Evidence-based Practice Center at Oregon Health Sciences University systematically reviews the evidence of the effectiveness of a wide range of clinical preventive services, including screening, counseling, and chemoprevention, in the primary care setting. The SERs comprehensive reviews of the scientific evidence on the effectiveness of particular clinical preventive services serve as the foundation for the recommendations of the USPSTF, which provide age- and risk-factor-specific recommendations for the delivery of these services in the primary care setting. Details of the process of identifying and evaluating relevant scientific evidence are described in the Methods section of each SER. The SERs document the evidence regarding the benefits, limitations, and cost-effectiveness of a broad range of clinical preventive services and will help further awareness, delivery, and coverage of preventive care as an integral part of quality primary health care. AHRQ also disseminates the SERs on the AHRQ Web site ( and disseminates summaries of the evidence (summaries of the SERs) and recommendations of the USPSTF in print and on the Web. These are available through the AHRQ Web site and through the National Guideline Clearinghouse ( We welcome written comments on this SER. Comments may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 540 Gaither Road, Suite 3000, Rockville, MD 20850, or uspstf@ahrq.gov. Carolyn M. Clancy, M.D. Director Agency for Healthcare Research and Quality Jean Slutsky, P. A., M.S.P.H. Acting Director Center for Outcomes and Evidence Agency for Healthcare Research and Quality The USPSTF is an independent panel of experts in primary care and prevention first convened by the U.S. Public Health Service in The USPSTF systematically reviews the evidence on the effectiveness of providing clinical preventive services--including screening, counseling, and chemoprevention--in the primary care setting. AHRQ convened the current USPSTF in November 1998 to update existing Task Force recommendations and to address new topics.

5 The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.

6 Dental Disease Prevention: The Physician s Role in Child Oral Health i Contents Chapter 1. Introduction.. 1 Epidemiology 1 Prevention.4 Guidelines for Prevention of Dental Caries.5 Access...7 Analytic Framework and Key Questions.10 Chapter 2. Methods 14 Studies Involving Primary Care Physicians...14 Studies in the Dental Literature.15 Chapter 3. Results...17 Accuracy of Screening by Primary Care Clinicians 17 Identifying Needed Referrals. 17 Effectiveness of Primary Care Clinician Referral to a Dentist Effectiveness of Fluoride Supplementation..20 Effectiveness of Professional Fluoride Application.26 Effectiveness of Counseling for Caries Prevention.30 Chapter 4. Discussion..33 Screening Accuracy..33 Referral Effectiveness..34 Effectiveness of Fluoride Supplementation..34 Appropriateness of Supplementation Decision.34 Parental Adherence..35 Effectiveness of Supplements.35 Effectiveness of Fluoride Application.38 Appropriateness of Application Decision...38 Effectiveness of Counseling 40 Adherence to Recommendations and Caries Prevention..40 Other Issues: Pediatric Medications Containing Sugar..41 A Research Agenda.42 References 45 Figure 1. Dental Care for Young Children from Primary Care Physicians: Analytic Framework...54 Table 1. Search Results on Studies of Primary Care Providers Involvement in Child Oral Health...55 Table 2 Sources of Data for Collateral Evidence from the Dental Literature 56

7 Dental Disease Prevention: The Physician s Role in Child Oral Health ii Table 3. Studies Reporting Screening Accuracy for Primary Care Providers 57 Table 4. Risk Indicators for Dental Caries in Children Suggested for Use in Dental Practice...58 Table 5. Studies Reporting Referral Effectiveness.59 Table 6. Physicians Knowledge of and Behavior Regarding Fluoride Supplementation 60 Table 7A. Effects of Fluoride Supplements on Primary Teeth: Study Design Characteristics 61 Table 7B. Effects of Fluoride Supplements on Primary Teeth: Study Results..62 Table 8A. Clinical Studies of Fluoride Varnish Applied to Primary Teeth: Study Design...63 Table 8B. Clinical Studies of Fluoride Varnish Applied to Primary Teeth: Results.65 Table 9. Summary of Systematic Reviews of the Effectiveness of Oral Health Promotion and Education.67 Appendix A. Acknowledgements A1 Appendix B..B1

8 Dental Disease Prevention: The Physician s Role in Child Oral Health 1 Chapter 1. Introduction Issues of oral health in children revolve almost exclusively around dental caries. In the United States, dental caries is the most common chronic childhood disease, 1 and its treatment is the most prevalent unmet health need in children. 2 A substantial portion of caries lesions can be prevented; indeed, the incidence of this disease has declined among school-age children and adults in the past three decades. However, incidence among preschool children has not declined at a similar rate over this same time period. Epidemiology Dental caries is an infectious disease that can occur when cariogenic bacteria colonize a tooth surface in the presence of dietary carbohydrates, especially refined sugars. The bacteria metabolize the carbohydrates, producing lactic acid, which over time demineralizes the tooth structure. 3 The earliest visible manifestation of dental caries is the appearance of a demineralized area on the tooth surface, which presents either as a small white spot on a smooth surface or a pit or fissure. At this stage, a caries lesion is usually reversible. If oral conditions do not change, demineralization will continue with the eventual result that the tooth surface loses its natural contour and a cavity develops. At this stage, restorative treatment is necessary to prevent the continuation of the caries process, which if left untreated will eventually result in pulpitis and ultimately tooth loss. Progression of individual caries lesions is typically slow, but it can be extremely rapid in a small proportion of individuals and especially in primary teeth, which have thinner enamel. Because dental caries is a chronic disease of microbial origin, modified by diet, the elimination

9 Dental Disease Prevention: The Physician s Role in Child Oral Health 2 of active caries lesions through treatment does not necessarily mean that the disease has been eradicated. An individual s risk for dental caries can change with time as etiologic factors change, leading to new caries events around already treated lesions or on previously unaffected tooth surfaces. Dental caries can occur soon after eruption of the primary teeth, starting at 6 months of age. The most recent national survey ( ) indicated that 52% of children 5 to 9 years of age have experienced dental caries; 4 of children 2 to 5 years of age, 18.7% have at least 1 primary tooth with untreated decay. 5 Referred to as early childhood caries (ECC), dental caries in preschool children can take several forms. The most severe form has a pattern of early initial attack on the maxillary incisors with the attack continuing on other teeth as they erupt. 6 Dental caries incidence begins in the permanent teeth at about 6 years with the eruption of central incisors and first molars. Among children 5 to 11 years of age, 26% have experienced one or more lesions in permanent teeth; this proportion increases to 67% among adolescents 12 to 17 years of age. 7 Dental caries is unequally distributed among the population. Caries incidence, prevalence, and severity is greater in minority and economically disadvantaged children. 2,4,5,8 Among children 1 to 2 years of age examined in the most recent national survey, all who had obvious dental caries in the maxillary incisors were in the group with incomes at or below 200% of the federal poverty line. 9 Among children 2 to 5 years of age, those in families at or below the poverty level are 106% more likely to have experienced dental caries than children in families with incomes above the poverty level. 5 At this same age, black children have 43% more untreated carious primary teeth than white children, and children at or below the federal poverty line have 138% more than children above the poverty line. 10

10 Dental Disease Prevention: The Physician s Role in Child Oral Health 3 Dental caries in primary teeth can has both short- and longer-term negative consequences. Caries lesions often cause pain because they can progress rapidly in primary teeth and involve the pulp before they are either detected or treated. About 1 in 10 children 2 to 17 years of age and 1 in 5 children from low-income families made dental visits because they were in pain or something was bothering them. 11 Regardless of their degree of progression, lesions cavitated into dentin require reparative treatment or tooth extraction; both are frequently traumatic experiences for young children. Young children with untreated, symptomatic carious teeth often present to emergency departments of hospitals for their first dental visit. 12 Also, untreated caries lesions in young children may be associated with failure to thrive, 13 although evidence is conflicting regarding this association. 14 Social outcomes of dental caries in young children are poorly documented, but children 5 to 7 years of age in the United States have been estimated to lose more than 7 million school hours annually because of dental problems and/or visits. 15 Untreated caries typically is cited as leading to increased infections, dysfunction, poor appearance, and low self-esteem, 16 but most of these associations stem from conventional wisdom rather than observational studies. Longer-term consequences of dental caries in primary teeth include an increased probability of caries in the permanent dentition 17,18 and possible loss of arch space. Lack of treatment for caries in primary teeth will often result in the premature loss of the primary teeth, especially molars, which are at risk for the longest period. Premature loss of primary molars can lead to loss of arch space as the first permanent molars drift into the missing tooth spaces. 19 The result can be crowding of the permanent teeth, the severity of which depends on the amount of lost space. Anterior tooth crowding affects aesthetics and may necessitate orthodontic treatment for correction.

11 Dental Disease Prevention: The Physician s Role in Child Oral Health 4 Some dentists believe that crowding increases the risk of both caries and periodontal disease in the permanent dentition because of the disruption of normal tooth-to-tooth relations that promote self-cleaning. This widely held belief is not well supported by observational studies, however. Prevention Approaches to the prevention of dental caries involve attempts to reduce the microbiological burden, reduce the availability of refined sugars, increase the resistance of teeth, or some combination of these approaches. Reducing the microbiological burden is the focus of interventions using antimicrobial rinses and dentifrices and behavioral interventions to improve oral hygiene and thus remove the bacterial plaque coating tooth surfaces. Behavioral interventions are also used to reduce the availability of fermentable carbohydrates through changes in the composition of the diet and frequency of ingestion of refined sugar. Increasing the resistance of teeth is typically achieved through the use of sealants and fluorides. Sealants are applied to the occlusal surfaces of molars and premolars, denying bacteria access to these often hard-to-clean areas. Fluorides are used both topically (fluoride dentifrices, rinses, gels, foams, and varnishes) and systemically (fluoridated water, dietary fluoride supplements) for both prevention and management (i.e., remineralization) of dental caries. After exposure, fluoride becomes available in plaque, saliva, and the tooth s outer layer, where it increases resistance to acid dissolution, serves as a reservoir for remineralization of the initial caries lesions, or acts as a bacterial inhibitor when released through acid dissolution. 3,20 Another approach currently receiving attention but not yet widely endorsed attempts to eliminate transmission of cariogenic

12 Dental Disease Prevention: The Physician s Role in Child Oral Health 5 bacteria from caregiver to child through the use of antimicrobial and behavioral interventions to reduce the reservoir of bacteria in the caregiver. 21,22 Guidelines for Prevention of Dental Caries A growing number of guidelines provide recommendations on individual, professional, and community interventions to prevent and control dental caries. 4,23-30 Most recently, the Task Force on Community Preventive Services has supported the effectiveness and safety of community water fluoridation; like several of the more recent guidelines, this statement is based on systematic reviews of the evidence of effectiveness and safety. 31 In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended (in Chapter 61 of the Guide to Clinical Preventive Services) counseling patients to visit a dental care provider on a regular basis, floss daily, and brush their teeth daily with fluoride-containing toothpaste based on evidence of risk reduction from these interventions. 32 The USPSTF also recommended counseling caregivers to avoid putting infants and children to bed with a bottle. Dietary fluoride supplementation (hereafter referred to as fluoride supplementation) of persons 6 months to 16 years of age who drink water with inadequate fluoride was recommended based on well-designed controlled trials. The 1995 Canadian Task Force on Preventive Health Care (CTFPHC) focused on dental interventions per se; they recommended water fluoridation, fluoride supplementation in lowfluoride areas, professional topical fluoride, and self-administered fluoride mouth rinses for persons with active decay or specific risk factors, and use of fluoride dentifrice. 24 An expert panel convened by the Centers for Disease Control and Prevention (CDC) recently conducted a critical analysis of scientific evidence regarding the efficacy and

13 Dental Disease Prevention: The Physician s Role in Child Oral Health 6 effectiveness of fluoride modalities in the prevention and control of dental caries. 27 Fluoride toothpaste, mouth-rinse, gel, and varnish were recommended based on the quality of the evidence of effectiveness. For the first time, the evidence of effectiveness for fluoride supplements was graded according to age. Prenatal supplements were not recommended based on the results of a single randomized controlled trial. Supplements were recommended for children and adults, but only for those at high risk for dental caries. The evidence for caries prevention was judged to be good for school-aged children and poor for preschool-aged children and adults; but targeting high-risk patients was based on expert opinion alone. The American Academy of Pediatrics (AAP) has endorsed the CDC fluoride guidelines, thus supporting (a) community water fluoridation and fluoride toothpaste for use by the general population and (b) targeted use of professional fluoride products, including prescription of dietary fluoride supplements. 30 The American Dental Association (ADA) in one of its widely distributed publications also recommended limiting the use of dietary fluoride supplements and other professional fluoride products to patients with moderate to high caries risk (i.e., having 1 or more risk indicators for dental caries). 23 Guidelines on fluoride therapy published by the American Academy of Pediatric Dentistry (AAPD) are not specific on use of fluoride according to caries risk. 25 Other than the CDC fluoride guidelines for dietary fluoride supplements and fluoridated toothpaste, none of these guides is specific to young children. Appendix B provides a comparison of guidelines for supplements (Appendix Table B1) and professional application of fluorides (Appendix Table B2).

14 Dental Disease Prevention: The Physician s Role in Child Oral Health 7 Access Several dental organizations, including the AAPD and the ADA, recommend a first dental visit when a child is about 1 year of age. 33 Bright Futures recommends a dental appointment beginning at 12 months of age also, a stance that is endorsed by more than two dozen health organizations. 34 Available information suggests that the majority of children see a dentist for the first time rather later in life, but national data on age at first dental visit are not available. Data from the Medical Expenditures Panel Survey and the National Health and Nutrition Examination Survey describe proportions of the child population 2 to 5 years of age who had a visit in the past year; estimates vary from 20% 35 to 30%, 36,37 suggesting that the mean age at first visit is more likely between 3 and 5 years. More recent data will be necessary to determine if the public and dental professions are following the newer guidelines on age at first dental visit. Access to dental care for young children enrolled in Medicaid is a particularly severe problem. Of children 1 to 5 years of age enrolled in the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Program, 16% receive any preventive dental care even though all are eligible for these benefits. 4 A large percentage of young children with early childhood caries are able to get only emergency dental services, at best. A study of North Carolina s Medicaid population found that as few as 2% of 3-year-old enrolled children received comprehensive care in a 12-month period. 38 Reasons for the poor access that young children have to dental services are numerous and complex. Two situations in particular contribute to the access problem. First, general dentists are reluctant to treat young children; only a limited number of dentists have specialty training in their care. About 3,600 pediatric dentists nationwide supply 1 pediatric dentist for every 6,000

15 Dental Disease Prevention: The Physician s Role in Child Oral Health 8 children younger than 6 years of age. 11 Second, in most states, Medicaid reimburses dentists only a fraction of their usual, reasonable, and customary charges, making the treatment of any Medicaid patients financially unattractive. Compounding the problems of access to care for Medicaid and uninsured children is that the dental safety net does not function well in most areas of the country. Local, state, and federal dental programs have limited resources to meet the dental needs of those populations with limited access to private dental care. 4 For example, 4 major federal programs target underserved populations: the Health Center program that funds community and migrant health centers, the Indian Health Service dental program, and the National Health Service Corps and Indian Health Service loan repayment programs, both of which provide incentives for dental providers to practice in medically underserved areas. The General Accounting Office assessed all of these programs as having only a limited effect on improving access to dental services for their targeted populations. 36 Use of ambulatory health care in the medical office setting during the first year of life and from 1 to 4 years is 78% and 84.1%, respectively. 39 Use of dental care is 0% and 19.2%, respectively, for these same 2 age groups, demonstrating the large difference in utilization of medical care and dental care by young children. Problems with access to dental care underscore the role that primary care physicians and other child health care providers can play in providing access to preventive dental services, particularly for very young children and those who do not have access to dental care. Among young children who have experienced dental caries, a professional preventive intervention for dental caries presumably would have reduced or eliminated the incidence of disease. Yet, many children do not make a dental visit until well

16 Dental Disease Prevention: The Physician s Role in Child Oral Health 9 after the disease has progressed beyond the reversible stage. Also, those least likely to make an early dental visit are those most likely to have dental caries. Physicians and other primary care clinicians (PCCs) see child patients during this at-risk age before the first dental visit, providing an opportunity for them to take preventive action. Recommendations for physician interventions addressing dental caries include oral health screening and referral when indicated, provision of oral hygiene, dietary information, and anticipatory guidance to parents, and prescription of fluoride supplements. 30,34 PCCs also now apply fluoride varnish. The USPSTF has limited its consideration of dental health to issues associated with prevention of dental caries in preschool children. Although the complete scope of prevention of dental diseases is much wider, the rationale for focusing on preschool children and dental caries is compelling. As noted, physicians have a role in providing dental preventive services to young children. Physicians are much more likely to see preschool children than are dentists, a situation that does not reoccur until late in life. The caries process can start at an age when most children have not visited a dentist, reducing the potential for preventive interventions by dentists and permitting extensive destruction before dental intervention. Well-defined preventive procedures within the scope of medical practice are available for physicians to utilize in this preschool population. Thus, a sound theoretical basis exists for a focus on the role of physicians in the prevention of dental caries in preschool children. This review is not intended to suggest that the role of the physician should supplant the role of the dentist in maintaining the oral health of preschool children. Rather, the fundamental assumption of the review is that the responsibility for management of a child s oral health is shared among PCCs and dentists, and major

17 Dental Disease Prevention: The Physician s Role in Child Oral Health 10 responsibility is transferred from a PCC to a dentist at a point in time arranged jointly by the PCC, parents, and dentist. This report represents a departure from the chapter on Oral Health that appeared in the 1996 edition of the Guide to Clinical and Preventive Services. That chapter focused on counseling for the prevention of dental diseases in all ages. This summary of evidence focuses exclusively on the evidence of effectiveness for procedures applied by physicians and other primary care clinicians to prevent carious lesions in young children. Because of these different emphases, many of the recommendations from the 1996 Guide to Clinical and Preventive Services are not reexamined in this report. Analytic Framework and Key Questions The analytic framework for this review (Figure 1) represents a risk-based approach to the prevention and management of dental caries. It begins with a child s visit to a PCC, presumably a well-child visit. The PCC screens the child for both the presence of dental caries and risk indicators for dental caries. Depending on the results of the screening (either identification of suspected caries lesions or recognition of elevated risk for dental caries), the physician either refers the child to a dentist or initiates one or more preventive interventions (prescription of supplemental fluorides, application of fluoride varnish in the office, counseling the parents concerning caries preventive behaviors). The counseling intervention may include referral as well. If no disease or risk factors are identified, the PCC may also undertake counseling. This arm as well as the outcomes of treatment by dental professionals, are shown by dotted lines, indicating that we did not evaluate them in this review.

18 Dental Disease Prevention: The Physician s Role in Child Oral Health 11 The framework is intended to outline general types of interventions that PCCs provide and that are appropriate to children between birth and 5 years of age. Although prenatal counseling is recommended by some professional health care organizations and may be appropriate, it is not a focus of this review. Similarly, application of dental sealants, another effective dental care preventive service, is outside the scope of the review because it is unlikely to be feasible for PCCs to provide this service. We developed 5 key questions to direct the review. 1. How accurate is PCC screening in identifying children ages 0 to 5 years who: (a) have dental caries requiring referral to a dentist? (b) are at elevated risk of future dental caries? 2. How effective is PCC referral of children ages 0 to 5 years to dentists in terms of the proportion of referred children making a dental visit? 3. How effective is PCC prescription of supplemental fluoride in terms of: (a) appropriateness of supplementation decision? (b) parental adherence to the dosage regimen? (c) prevention of dental caries? 4. How effective is PCC application of fluoride in terms of: (a) appropriateness of application decision? (b) achieving parental agreement for the application? (c) prevention of dental caries? 5. How effective is PCC counseling for caries-preventive behaviors as measured by: (a) adherence to the desired behavior? (b) prevention of dental caries?

19 Dental Disease Prevention: The Physician s Role in Child Oral Health 12 For Key Question No. 5, the caries-preventive behaviors of interest relate to diet (reduction in frequency and amount of sucrose, appropriate use of the bottle), oral hygiene (brushing frequency and efficacy), dental attendance (regular dental examinations and first visits for assessment of risk of disease), appropriate use of fluoride (accepting professional recommendations, use of fluoride dentifrice at home), and implications of caregiver oral health (possible transmission of cariogenic bacteria).

20 Dental Disease Prevention: The Physician s Role in Child Oral Health 14 Chapter 2. Methods For each of the 5 key questions, we first searched the literature for studies that involved primary care practitioners. Because we anticipated finding only a limited number of studies addressing the performance of PCCs in these essentially dental roles, we also planned from the outset to address Key Questions 3, 4 and 5 using the dental literature. Our approach here was to base the appraisal of the evidence on existing systematic and traditional reviews of the literature whenever possible. Studies Involving Primary Care Clinicians We used separate searches for 3 of the 5 key questions; we combined the 2 fluoriderelated questions (Key Questions 3 and 4) into a single search. We searched the English language literature in MEDLINE from 1966 to October Appendix Tables B3-B6 detail the search terms and numbers of articles produced for each term for each of these searches. We used combinations of (a) terms defining primary care providers or primary care sites and (b) terms defining the dental topics embodied by the individual questions. Our initial searches included terms capturing a wide range of research designs, from randomized controlled trials (RCTs) through questionnaire surveys. We then added any studies we identified in the Cochrane Controlled Trials Register and those identified through review of the references in papers found by the searches and through personal knowledge. For each of the resulting 4 sets of papers, 2 reviewers independently reviewed each abstract to identify those studies eligible for full review. Criteria for this level of review were simply that the study addressed the key question, reported original data, and involved primary

21 Dental Disease Prevention: The Physician s Role in Child Oral Health 15 care practitioners. Papers undergoing full review for inclusion were subjected to the same set of criteria. When we identified studies, we prepared abbreviated evidence tables summarizing their content. Studies in the Dental Literature Because of the small number of studies identified that involved PCCs, we pursued our planned strategy of using a combination of existing reviews and new searches in the dental literature to provide necessarily collateral evidence of effectiveness for 3 questions: supplemental fluoride, applied fluoride, and counseling for caries preventive behaviors. We identified recent systematic reviews that addressed the effectiveness of applied fluoride and counseling. We could not identify an appropriate review for the effectiveness of prescribed supplemental fluoride for caries reduction in primary teeth, regardless of who made the prescription. Although reviews on the topic were numerous, none included the collection of studies that we thought pertinent to the key question. Therefore, we performed a modified systematic review for this question wherein we identified all possible studies by searching and examining reviews of the topic and then searching forward from the most recent review (Appendix Table B7). We included controlled prospective studies in English in which the intervention began before 5 years of age and investigators assessed outcomes for primary teeth and/or permanent teeth. We accepted the absence of baseline prevalence data when initiation of supplementation occurred before eruption of the primary teeth. The controlled, prospective study criterion excluded more than half of the English language studies traditionally cited in support of the effects of supplementation in primary teeth, which employed retrospective or

22 Dental Disease Prevention: The Physician s Role in Child Oral Health 16 cross-sectional designs with no assignment or baseline examination (Appendix Table B8). We used a separate recent systematic review of fluorosis associated with the dietary intake of fluorides to assess the harms associated with supplements, as most of the included studies did not address this outcome. 40

23 Dental Disease Prevention: The Physician s Role in Child Oral Health 17 Chapter 3. Results Table 1 summarizes the results of the searches for studies involving PCCs. It shows (a) the number of studies initially identified by the search, (b) the number of additional studies identified through other sources, (c) the number of these studies that either of 2 reviewers targeted for detailed review, and (d) the number found to address the key question irrespective of the research design employed by the study. Table 2 summarizes the sources of collateral evidence for effectiveness from the dental literature for 3 key questions. Accuracy of Screening by Primary Care Clinicians Identifying Needed Referrals We considered screening to consist of visual oral examination and parental interview. We searched only for reports involving accuracy of the visual examination in identifying treatment needs requiring referral to a dentist. We found 2 studies germane to the visual oral examination component of PCC screening accuracy among children; both reported the performance of a single PCC visual screener, a nurse and a pediatrician (Table 3). 41,42 The pediatrician identified presence or absence of nursing caries, i.e., a caries lesion on any teeth other than mandibular incisors through examination with a mirror among children 18 to 36 months of age. No criteria for visual recognition of caries were reported, and 4 hours of training were provided. The comparison standard was a similar screening by a pediatric dentist. The nurse identified presence or absence of caries lesions, restorations, fluorosis, intraoral injuries, sealants, and urgent and nonurgent treatment needs

24 Dental Disease Prevention: The Physician s Role in Child Oral Health 18 among children 5 to 12 years of age using a flashlight and tongue blade. Caries lesions were to be noted only if cavitation (loss of surface continuity) was present. Five hours of training preceded the assessment. The comparison standard was a visual-tactile screening examination by a dentist. In both studies, the clinicians achieved high levels of screening accuracy (sensitivity and specificity) for dental caries following training. Sensitivities were 100% and 92% and specificities were 87% and 99% for the pediatrician (20% prevalence) and nurse (35% prevalence), respectively. 41,42 The nurse performed similarly in identifying children with restorations but was less accurate in identifying fluorosis, injuries, sealants, and nonurgent treatment. Many of the children in this study were older than 5 years, which may have reduced behavioral problems, thereby improving examination conditions. Identifying Elevated Risk for Caries Although formal risk categorization is infrequent in current dental practice, its use has been encouraged. 43,44 The number of risk indicators for dental caries is large, 18,28 and subsets of these indicators are frequently suggested for use in dental practice. Table 4 lists risk indicators identified in 2 widely distributed sources, the Bright Futures project from the Health Resources and Services Administration (HRSA) 34 and the Journal of the American Dental Association s special supplement on caries diagnosis and risk assessment. 23 The clinical risk indicators most accessible for PCC to use in screening preschool children are the presence of caries lesions, plaque retention, and the presence of white spots or other evidence of demineralization, such as discolored pits and fissures of teeth. PCCs might ascertain several of the socio-environmental and behavior indicators by interview or questionnaire, and they may already be available through health history and behavioral data that

25 Dental Disease Prevention: The Physician s Role in Child Oral Health 19 are routinely collected. Nevertheless, we found no studies that examined PCC accuracy in identifying children who displayed one or more risk indicators using these or other risk indicators, with the exception of the studies summarized under key question 3a, which examine the appropriateness of PCC s decisions regarding fluoride supplements. Effectiveness of Primary Care Clinician Referral to a Dentist A single case study reported on the effectiveness of PCC referral (Key Question No. 2). 45 The study (Table 5) examined the effectiveness of referrals to dentists made by health professional assistants for the Women, Infants and Children (WIC) Supplemental Food Program for eligible children ages 6 months to 5 years. Children who were referred on the basis of nonnormal findings during intraoral screening examinations were almost twice as likely to have made a dental visit in their lifetime than children who were not referred, 37% compared to 19%. The study did not control for time elapsed since the referral had been made, and the difference in the visit rates was not significant when controlled in a multivariate analysis for child age, maternal age, household size, presence of dental insurance, and mother s perception of the child s dental needs. We did not examine collateral evidence in the dental literature for this question because no parallel situation exists. A study that did not meet the inclusion requirement of patient contact in an office or clinic environment reported still less effective results. 46 When health visitors in England referred children ages birth to 2 years to dentists for dental examinations, 21% of those referred actually visited a dentist.

26 Dental Disease Prevention: The Physician s Role in Child Oral Health 20 Effectiveness of Fluoride Supplementation Appropriateness of Supplementation Decision We identified 12 studies that addressed the appropriateness of PCCs prescription of supplemental fluorides; of these, 10 were surveys of physicians knowledge and behavior concerning fluoride supplementation (Table 6) These studies offer only indirect evidence concerning the appropriateness of fluoride supplementation in young children because they constitute self-reported physician data and do not assess prescribing behaviors for individual children. The survey items are too dissimilar and the results too heterogeneous to permit quantitative synthesis. Although survey results vary considerably, in general a large proportion (more than 75%) of pediatricians and a lesser proportion of family practitioners have reported providing supplemental fluoride to at least some of their child patients. Individual questions in some of the surveys indicated, however, that at the community and individual levels, physicians were not perfectly informed about local fluoridation status, which may lead to inappropriate supplementation decisions. In 2 studies, 48,50 only 69% and 74% of pediatricians and 26% and 58% of family practitioners reported knowing the fluoridation status of their practice areas. Only small proportions of physicians ever reported using water sample analyses to determine fluoride levels for individual water supplies. 51,52,54,55 In another study, 56% and 71% of physicians practicing in large and smaller fluoridated cities, respectively, reported prescribing supplements, signaling possible inappropriate supplementation. 53 Finally, in 1 study, 15% of family physicians and 9% of pediatricians indicated making no inquiries about fluoridation status before prescribing fluoride supplements. 52

27 Dental Disease Prevention: The Physician s Role in Child Oral Health 21 Further, physicians age-specific dosage recommendations were often different from recommendations from the AAPD or the ADA. The right-most column in Table 6 summarizes the percentage of appropriate responses to survey items regarding age-specific dosage and recommended prescribing procedures. Pediatricians tended to answer appropriately more often than other physicians. Apart from the differences evident in the 2 surveys by Margolis and colleagues (in 1980 and 1987), 47,53 we could see no indications that physician knowledge has improved in the past two decades. Similarly, no obvious change has occurred in the proportion of physicians who prescribe fluoride supplements to at least some of their patients. Two patient-based assessments of appropriate management of fluoride supplementation have been reported. 57,58 Twenty family medicine residents improved their knowledge of systemic fluoride therapy following a videotape presentation, but the percentage of patients appropriately managed did not change, remaining around 60%. In contrast, 88% of children visiting a single family health center were managed appropriately immediately following the institution of a new protocol. The pre-protocol level of appropriate management was estimated to have been no more than 25%. Primary care providers in the study were 2 family physicians, 1 physician assistant, and an unknown number of medical students. This study did not follow up to determine whether appropriate management was maintained at the higher post-protocol level over the longer term. Parental Adherence We found no eligible studies of PCC effectiveness in terms of the level of parental adherence achieved with the daily dosage regimen. Our review of the dental literature similarly found no studies of effectiveness of dentists with respect to gaining parental adherence.

28 Dental Disease Prevention: The Physician s Role in Child Oral Health 22 Indirect evidence is available for this question from adherence information collected during some supplement trials and from studies of population cohorts. Based on recent parental estimates, among Iowa infants receiving supplements at any time in the first 12 months, the mean daily dose over the full year was 0.07 mg, far less than the recommended 0.25 mg. 59 Parental adherence in providing supplements for Swedish preschool children had been no better two decades earlier. 60 Parental reports indicated that 51% of children had received supplements at some time during ages 6 months to 7 years; 12% had taken supplements regularly for a minimum of 5.5 years. Similarly, among Australian children who began receiving supplements early in life, only 18% received them regularly by age 5 to 6 years. 61 In a group of Canadian children 3 to 9 years old, of 35% reported to be using supplements at a certain point, 58% had discontinued their use within 1 year. 62 Prevention of Dental Caries Tables 7A and 7B summarize 6 trials of the effectiveness of fluoride supplements in preventing dental caries in primary teeth when the supplementation was initiated before the age of 5 years These studies represent a variety of designs in terms of age at first use of fluoride, dosage, background fluoride level, duration of the trial, and assignment method (Table 7A). Across these differences, reductions in the number of both teeth and tooth surfaces with caries lesions were consistently associated with use of supplements (Table 7B). The ranges of percentage reductions were 32% to 72% for primary teeth and 38% to 81% for primary tooth surfaces. The smallest proportional reductions occurred in the study with the highest background fluoride level, a level that is not considered appropriate for supplementation under current guidelines. 25 All reported statistical tests were significant.

29 Dental Disease Prevention: The Physician s Role in Child Oral Health 23 These studies indicate that fluoride supplementation is effective in preventing dental caries; numbers needed to treat (NNTs) to prevent 1 additional carious tooth surface over 1 year ranged from 0.3 to 1.5. Nontheless, generalization of these results must be done cautiously. Dropout rates in 2 studies were high (approximately two-thirds of the original samples); the dropout rate could not be determined in 2 studies. Two other studies with lower dropout rates involved a school-based program and a Taiwanese study of cleft palate children, where parental motivation may have been high because of both societal norms and other childcare requirements. No study used an intent-to-treat analysis. Equally as problematic, assignment method could not be determined in 4 studies. Not shown in Table 7 are data about caries reductions for permanent teeth associated with use of fluoride supplements initiated before age five. Two such studies met our inclusion criteria; both are extensions of studies described in Table 7. Margolis et al reported total permanent tooth caries increments at ages 7 to 10 years for children taking fluoride supplements since age 1 to 4 months. 65 Compared to controls, the total number of permanent teeth experiencing caries was reduced 58% and 33% in 2 communities. The latter reduction was not statistically significant; only 28 intervention group children were available for examination in this community. Hamberg reported a 70% to 80% reduction in caries increments at age 7 to 8 years among first molars in the supplement group compared to controls but gave no statistical testing information. 63 These reductions mirror the wide range of statistically significant reductions in caries experienced in permanent teeth when supplementation has been started later, as a part of a school-based program. 69

30 Dental Disease Prevention: The Physician s Role in Child Oral Health 24 Enamel Fluorosis Enamel fluorosis is the only harm that can result from the use of dietary fluoride supplements and that is only of aesthetic importance. 70,71 This condition is characterized by a continuum of changes in the enamel that result from increasing degrees of hypomineralization. The very mild forms of fluorosis appear as chalklike, lacy markings across a tooth s enamel surface. Most often these slight changes are visible only when the enamel is dried and viewed under direct and careful observation. As the severity of fluorosis increases, larger areas of the enamel surface are affected and it can be observed during normal day-to-day personal interactions. The threshold at which fluorosis generally is thought to be noticeable by the public is when more than one-fourth of the enamel surface of a visible tooth is affected with a change in color from its normal, glossy creamy white appearance to an opaque-white appearance (mild or greater according to Dean s criteria). 71 The prevalence of fluorosis has increased during the last 50 years The only national survey of fluorosis in the United States found a prevalence of 23.5% for permanent teeth in children 5 to 17 years of age (13.5% in children attending schools with < 0.3 ppm F; 21.7% with 0.3 to 0.7 ppm F; 29.9% with 0.7 to 1.2 ppm F). 74 Almost all cases were of the very mild form. About 13.1% of children who were continuous residents of nonfluoridated communities had very mild fluorosis; the figure was 28.3% in fluoridated communities. The prevalence of cases in children considered to be of some aesthetic consequence by dental professionals or the public is between 3% and 7%. Dietary fluoride supplements are a primary risk factor for fluorosis. 40 A recent systematic review examined individuals risk of enamel fluorosis resulting from the regular use of fluoride supplements in nonfluoridated communities among children birth to 6 years of age. 40 The review included 10 cross-sectional studies that depended on parental recall to identify extent

31 Dental Disease Prevention: The Physician s Role in Child Oral Health 25 of exposure to supplements and 4 follow-up studies in which supplement use had been recorded earlier and outcomes were determined via subsequent clinical examinations. In general, the dosage(s) used in these studies exceeded current recommendations. Prevalence of fluorosis associated with regular use ranged from 10% to 49% in the crosssectional studies; incidence ranged from 15% (on central incisors only) to 67% in the follow-up studies. The cross-sectional studies identified odds ratios of dental fluorosis associated with regular use during the early years of life ranging from 1.3 to Meta-analyses using 3 different approaches (Mantel-Haenszel, generalized variance, DerSimonian-Laird) gave summary odds ratios of 2.6, 2.6, and 2.4; the widest 95% confidence interval (CI) was 1.7 to 4.1. For the follow-up studies, individual relative risks ranged from 4.2 to 15.6; summary relative risks derived using the three meta-analytic approaches were 12.2 (95% CI, ), 5.6 (95% CI, ), and 5.5 (95% CI, ). The review concluded that use of fluoride supplements increases the risk of developing dental fluorosis, even though the condition is very mild in the large majority of children. No analysis of the proportion of all children experiencing fluorosis who will experience more severe forms was presented, largely because the original studies did not report these data. Pendrys has calculated attributable risk estimates for dietary fluoride supplements for middle school children living in several communities in Massachusetts and Connecticut. 76 After adjusting for a several other fluoride sources, nearly two-thirds of the cases of mild-to-moderate enamel fluorosis (i.e., greater than 50% of at least 2 tooth surfaces as defined by the Fluorosis Risk Index having paper-white streaking, coalescences to opacities, or both) observed in nonfluoridated areas (prevalence of 39%) could be attributed to the use of supplements with the pre-1994 dosage schedule. The other one-third of cases could be attributed to the early use of

32 Dental Disease Prevention: The Physician s Role in Child Oral Health 26 fluoride toothpaste. As many as 13% of cases in fluoridated communities (prevalence of 34%) could be explained by the inappropriate use of supplements. Effectiveness of Professional Fluoride Application Fluoride products have been applied topically to the teeth of dental patients in the form of solutions, gels, and foams for many years. The fluoride product and protocol with the most data on clinical effectiveness is a 4-minute application of 1.23% sodium fluoride gel applied in a disposable tray that conforms to the dental arch. The effectiveness of this fluoride regimen in the prevention of dental caries in permanent teeth of school-aged children is well established. 77 However, adherence to this protocol is very difficult in the treatment of most preschool-aged children because the trays are cumbersome and sometimes uncomfortable for young children, particularly for the required application time, and children can swallow enough of the gel to cause them transient gastric irritation. Because of this latter reason, professional opinion is that gel should not be used in most children under 6 years of age. No clinical trial has tested this standard professional topical fluoride application for caries preventive effectiveness in preschool-aged children. Fluoride varnish, which was first marketed in the United States in 1994 after the Food and Drug Administration (FDA) approved it as a medical device (as a cavity liner), has overcome these difficulties in the professional application of topical fluorides to the teeth of very young children. Because of the infrequent use of topical fluorides other than fluoride varnish in young children and the absence of clinical trials of the caries preventive effectiveness of other products, the focus of this review is on fluoride varnish alone.